Price negotiation period for Spinraza and Evrysdi extended

Company and gov’t unable to reach an agreement on the scope of Expenditure Cap Type RSA

Attention rises on whether treatment options for SMA will increase by October this year

The companies of the spinal muscular atrophy (SMA) treatments ‘Spinraza’ and ‘Evrysdi’ failed to conclude drug pricing negotiations for their drugs within the deadline and began extended negotiations.

 

As a result, Spinraza reimbursement extension and Evrysdi’s new listing will only be possible in October at the earliest.

 

According to industry sources, the reason for the delay in negotiations for the two drugs is known to be the differences in opinions between the companies and the authorities on the Expenditure Cap that should be set, which is a type of Risk Sharing Agreement (RSA) scheme that is applied to drugs eligible for reimbursement through the pharmacoeconomic evaluation exemption system.

 

In other words, the companies were unable to agree on the cap that should be applied, in consideration of factors such as the expected amount of use and the number of patients.

 

Discussions on reimbursement and reimbursement extension of SMA treatments had seemingly gained speed in line with the movement that pressed for the abolition of Spinraza’s reimbursement suspension standard, but discussions were prolonged after a certain group requested a wider coverage than what the government and pharmaceutical companies expected.

 

At the time, the government announced plans to proceed with discussions on Evrysdi’s listing after agreeing on the reimbursement extension standards for Spinraza.

 

Both drugs were finally put on the final table for negotiations, but the news on the conclusion of the negotiations can only be expected in September.

 

Meanwhile, SMA treatments currently reimbursed in Korea include Spinraza and Novartis Korea's one-shot treatment, 'Zolgensma (Onasemnogene abeparvovec-xioi))'.

 

Spinraza is administered directly into the spinal fluid, and Zolgensma is administered intravenously.

 

Evrysdi, which is attempting new listing, is an oral drug that reduces the social and economic burden patients and their caregivers face due to injections, such as school/work interruption, transportation costs, and nursing care It also has the advantage of being able to reduce drug costs for infant patients as it offers customized prescriptions by age and weight.